FLOGOPROFEN Gel / Cutaneous spray solution Ref.[51140] Active ingredients: Etofenamate

Source: Medicines Authority (MT)  Revision Year: 2012  Publisher: Chiesi España, S.A.U., Plaça dEuropa, 41-43, Planta 10, 08908 LHospitalet de Llobregat, Barcelona (Spain)

4.1. Therapeutic indications

This medicine is indicated in adults and adolescents (over 12 years) for the local relief of mild and occasional pain and inflammation caused by: minor bruises, blows, strains, torticollis or other contractures, low back pain and mild sprains caused by a twist.

4.2. Posology and method of administration

Cutaneous use.

Adults and adolescents (over 12 years)

Apply a thin layer of gel or solution 3 or 4 times a day on the affected area and massage gently until absorbed.

Wash hands after each application.

Do not apply more than 7 consecutive days.

Children (younger 12 years)

Do not administer to children because of the lack of safety and efficacy data in this population.

Adults over 65 years

No dose modification is required for this group of patients.

4.9. Overdose

Due to its cutaneous use, poisoning is not likely to occur.

If the product has been incorrectly applied (for example: applying a large quantity of product in a short time), skin hypersensitivity, headache, dizziness or epigastric discomfort may occur. In this case, remove the medicinal product by washing the entire affected area with plenty of water.

In case of a large oral overdose, perform gastric lavage or induce vomiting and administer activated charcoal.

6.3. Shelf life

5 years.

6.4. Special precautions for storage

Flogoprofen 50 mg/g Gel:

For climatic zones I and II: No special storage conditions are required.

For climatic zones III and IV: Do not store above 30ºC.

Flogoprofen 50 mg/ml Cutaneous spray solution:

For climatic zones I and II: No special storage conditions are required.

For climatic zones III and IV: Do not store above 30ºC.

Highly flammable liquid. Keep away from flames, incandescents sources and excessive heat.

6.5. Nature and contents of container

Flogoprofen 50 mg/g Gel: Squeezable sealed aluminium tube with twist-off cap containing 30 g or 60 g of gel.

Flogoprofen 50mg/ml Cutaneous spray solution: Polyethylene spray bottle containing 100 ml of solution.

6.6. Special precautions for disposal and other handling

Flogoprofen 50 mg/g Gel: No special requirements.

Flogoprofen 50 mg/ml Cutaneous spray solution: Highly flammable liquid. Any unused medicinal product or waste material should be disposed of in accordance with local requeriments. Because of its ethanol content, as a precaution the bottle and its contents should be kept away from flames/fire (see section 4.4).

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